Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release
FDA Recall NDC 69452-206
Latest: Class III · Status: Ongoing · Initiated Aug 07, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Doxylamine Succinate And Pyridoxine Hydrochloride (NDC 69452-206). A significant event, classified as Class III, was initiated on Aug 07, 2026 by Bionpharma Inc.,. The reported reason for this action was: "Presence of Foreign Tablets/Capsules"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Presence of Foreign Tablets/Capsules
Aug 07, 2026
Sep 09, 2026
14,232 bottles (1,423,200 tablets)
Recall Profile & Regulatory Data
Event ID
99551
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Bionpharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.
Batch or Lot Expiration Information
Lot# DMA25006, Exp Date: 11/30/2028.
Affected Packages Involved in this Recall
69452-206-20Doxylamine Succinate And Pyridoxine Hydrochloride
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
